510(k) K080370 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
ABL 80 CO-OX SYSTEM
| Applicant | Sendx Medical, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Jul 31, 2008 |
| Received | Feb 12, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080370
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 11, 2020 | Radiometer Medical ApS ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting. Terminated |
CHL | None listed |
| Nov 5, 2012 | Sendx Medical Inc ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35).
The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximet Terminated |
CHL | None listed |
| Aug 30, 2012 | Sendx Medical Inc ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer System.
Intended Use The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with Terminated |
CHL | None listed |
| Nov 10, 2009 | Sendx Medical Inc ABL 80 CO-OX SYSTEM, software versions 1.30 and 1.31
Additional Product Codes: CEM, CGA, CGZ, GHS, GKR, GLY, JFP, JGS, JIX, JJY, JPI
The ABL 80 CO-OX SYSTEM is a portable, automated analyzer that me Terminated |
CHL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.